Lecanemab Gets Nod from CHMP for Use in Early Alzheimer’s Disease

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion to Eisai Europe and Biogen for the amyloid-beta (Ab) monoclonal antibody (mAb) lecanemab as a treatment for adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (early AD). CHMP’s decision, which was primarily based on data from a global Phase III clinical trial, was announced by Eisai in a Nov. 15. 2024 press release (1).

Patients in the European Union (EU), who will be eligible for treatment once the European Commission has made its final decision on the treatment, would be those who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology. ApoE is a protein that is involved in the metabolism of fats in humans and has been identified as the strongest genetic risk factor for sporadic AD and an important biomarker to determine disease susceptibility (2).

“[The] positive CHMP opinion brings us one step closer to being able to offer a potential treatment option which targets an underlying cause of AD to eligible patients in the EU for the first time,” said Gary Hendler, regional chairman and CEO, Eisai EMEA, senior vice-president and global corporate officer, Eisai Co. Ltd, Tokyo, in the press release (1). “AD is a progressive neurodegenerative disease that poses significant challenges to human health and wider society—the loss of someone’s memory and independence can have a significant impact on not only those living with the disease, but also their family and friends. Eisai is committed to making a meaningful difference to all those affected by AD, and we are pleased that our ongoing work with the CHMP is helping to make this available to eligible patients in the EU.”

CHMP’s opinion has been sent to the European Commission for its final review, with a decision on the marketing authorization application expected within 67 days of receipt of the opinion. Lecanemab is already approved in the United States, China, Japan, South Korea, Hong Kong, Israel, the United Arab Emirates, and Great Britain, and is under review in 17 countries.

“The positive CHMP opinion marks a significant step and recognizes the potential of this medicine to make a difference to eligible individuals and their families impacted by this disease. We look forward to the EC’s decision and are pleased to be one step closer to offering this medicine in the EU,” added Wolfram Schmidt, president, head of Europe, Biogen, in the press release (1). “As a company, we are dedicated to furthering Alzheimer’s disease research and treatment, aiming to help address the unmet needs in this devastating condition.”

Lecanemab (brand name Leqembi) is a humanized immunoglobulin gamma 1 (IgG1) mAb that selectively binds to soluble Ab aggregates (protofibrils) and insoluble Ab fibril aggregates. According to research, the reduction of Ab protofibrils has been highlighted as potentially useful in reducing the progression of AD (3).

References

1. Eisai. Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease. Press Release, Nov. 15, 2024.
2. Pires, M.; Rego, A.C. ApoE4 and Alzheimer’s Disease Pathogenesis—Mitochondrial Deregulation and Targeted Therapeutic Strategies. Int. J. Mol. Sci. 2023, 24 (1), 778.
3. Ono, K.; Tsuji, M. Protofibrils of Amyloid-b are Important Targets of a Disease-Modifying Approach for Alzheimer’s Disease. Int. J. Mol. Sci. 2020, 21 (3), 952.